The Effect of Ulipristal Acetate (UPA) on Women Ovarian Reserve

• Status: Unknown status
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The uterine leiomyoma is the most common female benign disease.UPA seems to be most effective for the medical management of fibroids and could be place as preoperative adjunct to surgery but also as medical therapy to avoid surgery. No data have been published about the effect of UPA on FSH (Follicle stimulating hormone) or AMH levels nor on ovarian antral follicle count (AFC) or vascularization indexes during and after treatment. Considering that in young women of reproductive age (under 40 years old), desiring pregnancy, UPA has been proposed to avoid or postpone surgery, also in a long-term administration program, data about its effect on women ovarian reserve are urgently needed.

For these reasons, data on biochemical (AMH, FSH and E2) and 3D ultrasonographic (VI, Flow index, AFC) parameters of women treated by UP are needed to assess the effect of the drug in terms of ovarian reserve modification.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Magna Graecia
• Treatments: Ulipristal acetate

Criteria

Inclusion Criteria:

• submucosal,

• intramural or subserosal leiomyomas,

• symptoms of menometrorrhagia,

• menstrual disorder,

• infertility,

• pelvic pain

Exclusion Criteria:

• endometrial hyperplasia with atypia,

• estrogen-progestin therapy in the 2 months before enrollment,

• autoimmune diseases,

• chronic, metabolic, systemic and endocrine disorders, including hyperandrogenism, hyperprolactinemia, diabetes mellitus and thyroid disease,

• hypogonadotropic hypogonadism,

• majors clinical conditions